Hemostasis devices with folded balloon assemblies

ABSTRACT

The present application discloses various embodiments of hemostasis devices with folded balloon assemblies.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application claims priority to U.S. Provisional Patent ApplicationNo. 62/812,436, filed Mar. 1, 2019, which is incorporated by referenceherein in its entirety.

FIELD OF THE DISCLOSURE

The present disclosure relates to hemostasis devices (e.g., bands) thatare adapted to act as compression devices to promote hemostasis at asurgical access site, and more particularly to hemostasis bands havingfolded balloon assemblies.

BACKGROUND

After a surgical procedure involving arterial or venous access, it maybe desirable or necessary to apply pressure to the vascular access siteto promote hemostasis. Some existing hemostasis devices use one or moreinflatable balloons to apply pressure to the access site. In someinstances, these balloons have experienced failures. Some existinghemostasis devices may also be time-consuming and expensive toconstruct. Accordingly, there is a need for hemostasis devices thataddress these and other drawbacks of the prior art.

SUMMARY OF THE DISCLOSURE

In one respect, the present disclosure comprises a balloon assembly fora hemostasis device, the balloon assembly comprising: a first chamber; asecond chamber; and at least one channel that is in fluid flowcommunication between the first chamber and the second chamber, whereina single perimeter of attachment between a first layer of material and asecond layer of material defines at least a portion of a perimeter ofthe first chamber, at least a portion of a perimeter of the secondchamber, and at least a portion of a perimeter of the at least onechannel.

In another respect, the present disclosure comprises a balloon assemblyfor a hemostasis device, the balloon assembly comprising: a connectorhaving a first air inlet, a first air outlet, and a second air outlet,the first air inlet being connected separately in fluid flowcommunication with each of the first air outlet and the second airoutlet; a first balloon having an inlet and an interior; a firstconnection tubing connected in fluid flow communication between thefirst air outlet and the interior of the first balloon via the inletthereof; a second balloon having an inlet and an interior; and a secondconnection tubing connected in fluid flow communication between thesecond air outlet and the interior of the second balloon via the inletthereof; wherein the first balloon and the second balloon are notconnected in direct fluid flow communication.

In yet another respect, the present disclosure comprises a balloonassembly for a hemostasis device, the balloon assembly comprising: afirst chamber; a second chamber; and at least one channel that is influid flow communication between the first chamber and the secondchamber; wherein the first chamber, the second chamber, and the at leastone channel are formed between a first layer of material and a secondlayer of material; wherein at least a portion of the first chamberoverlays at least a portion of the second chamber; and wherein the atleast one channel is folded.

FURTHER ASPECTS OF THE INVENTIVE CONCEPT(S)

Further aspects of the inventive concept(s) include:

Aspect 1: A balloon assembly for a hemostasis device, the balloonassembly comprising: a first chamber; a second chamber; and at least onechannel that is in fluid flow communication between the first chamberand the second chamber, wherein a single perimeter of attachment betweena first layer of material and a second layer of material defines atleast a portion of a perimeter of the first chamber, at least a portionof a perimeter of the second chamber, and at least a portion of aperimeter of the at least one channel.

Aspect 2: The balloon assembly of Aspect 1, wherein the single perimeterof attachment defines the entireties of the perimeters of the firstchamber and the second chamber.

Aspect 3: The balloon assembly of either of Aspect 1 or Aspect 2,wherein the single perimeter of attachment defines the entirety of theperimeter of the at least one channel.

Aspect 4: The balloon assembly of any of Aspects 1-3, the balloonassembly further comprising an exterior edge, wherein the at least onechannel is folded around the exterior edge and wherein at least aportion of the first chamber overlays at least a portion of the secondchamber.

Aspect 5: The balloon assembly of Aspect 4, wherein a first portion ofthe at least one channel overlays a second portion of the at least onechannel.

Aspect 6: The balloon assembly of any of Aspects 1-5, further comprisingat least one piece of secondary material located within the at least onechannel.

Aspect 7: The balloon assembly of Aspect 6, wherein the at least onepiece of secondary material is formed of a gas-permeable material.

Aspect 8: The balloon assembly of Aspect 6, wherein the at least onepiece of secondary material is formed of a gas-impermeable material.

Aspect 9: The balloon assembly of Aspect 6, wherein the at least onepiece of secondary material has a circular cross-sectional shape.

Aspect 10: The balloon assembly of any of Aspects 1-9, furthercomprising a third layer of material that is at least partially locatedbetween and attached to the first layer of material and the second layerof material.

Aspect 11: The balloon assembly of any of Aspects 1-10, the singleperimeter of attachment comprising an outer perimeter, the balloonassembly further comprising an inner perimeter of attachment between thefirst layer and the second layer, the inner perimeter being locatedinterior to the outer perimeter.

Aspect 12: The balloon assembly of Aspect 11, wherein the outerperimeter and the inner perimeter form a first air channel and a secondair channel between the first chamber and the second chamber.

Aspect 13: The balloon assembly of Aspect 12, further comprising acutout region interior to the inner perimeter from which portions of thefirst layer of material and second layer of material are absent.

Aspect 14: The balloon assembly of any of Aspects 1-13, furthercomprising an inlet located along the perimeter through which a fluidcan be introduced into an interior of the balloon assembly.

Aspect 15: The balloon assembly of Aspect 14, wherein the inlet is inthe form of a hollow cylindrical tubing.

Aspect 16: The balloon assembly of Aspect 14, wherein the inlet is inthe form of a chimney port or hose barb.

Aspect 17: The balloon assembly of any of Aspects 1-16, furthercomprising at least one attachment portion that is formed along a firstexterior edge of the balloon assembly.

Aspect 18: The balloon assembly of Aspect 17, wherein the at least onechannel is folded around the first exterior edge, and wherein at least aportion of the first chamber overlays at least a portion of the secondchamber.

Aspect 19: The balloon assembly of Aspect 17, wherein the at least onechannel is folded around an exterior edge of the balloon assembly thatis adjacent to the first exterior edge of the balloon assembly, andwherein at least a portion of the first chamber overlays at least aportion of the second chamber.

Aspect 20: The balloon assembly of Aspect 17, wherein the at least onechannel is folded around an exterior edge of the balloon assembly thatopposes the first exterior edge of the balloon assembly, and wherein atleast a portion of the first chamber overlays at least a portion of thesecond chamber.

Aspect 21: A balloon assembly for a hemostasis device, the balloonassembly comprising: a connector having a first air inlet, a first airoutlet, and a second air outlet, the first air inlet being connectedseparately in fluid flow communication with each of the first air outletand the second air outlet; a first balloon having an inlet and aninterior; a first connection tubing connected in fluid flowcommunication between the first air outlet and the interior of the firstballoon via the inlet thereof; a second balloon having an inlet and aninterior; and a second connection tubing connected in fluid flowcommunication between the second air outlet and the interior of thesecond balloon via the inlet thereof; wherein the first balloon and thesecond balloon are not connected in direct fluid flow communication.

Aspect 22: The balloon assembly of Aspect 21, wherein the first balloonand second balloon are physically connected together along a respectiveedge thereof.

Aspect 23: A balloon assembly for a hemostasis device, the balloonassembly comprising: a first chamber; a second chamber; and at least onechannel that is in fluid flow communication between the first chamberand the second chamber; wherein the first chamber, the second chamber,and the at least one channel are formed between a first layer ofmaterial and a second layer of material; wherein at least a portion ofthe first chamber overlays at least a portion of the second chamber; andwherein the at least one channel is folded.

Aspect 24: The balloon assembly of Aspect 23, wherein the at least onechannel is wrapped around an exterior edge of the balloon assembly.

Aspect 25: The balloon assembly of Aspect 24, wherein the at least onechannel is folded such that a first portion of the at least one channeloverlays a second portion of the at least one channel.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will hereinafter be described in conjunction withthe appended drawing figures, wherein like numerals denote likeelements.

FIG. 1 is a partial perspective view of a hemostasis device including aballoon assembly according to the prior art, in an uninflated state;

FIG. 2 is a top view of a balloon assembly according to the prior art,in an uninflated state;

FIG. 3 is a perspective side view of a hemostasis device including aballoon assembly according to the prior art, in an inflated state,attached around an arm of a patient;

FIG. 4 is a top perspective view of a hemostasis device according to thepresent disclosure including a folded balloon assembly according to oneembodiment of the present disclosure, with the folded balloon assemblyshown in an uninflated state;

FIG. 5 is a schematic top view of the balloon assembly of the embodimentof FIG. 4, shown unfolded while in an uninflated state;

FIG. 6 is a top perspective view of the balloon assembly of theembodiment of FIG. 4, shown folded while in its uninflated state;

FIG. 7 is a side view thereof;

FIG. 8 is a top perspective view of a hemostasis device including theballoon assembly of the embodiment of FIG. 4, shown folded while in aninflated state;

FIG. 9 is a perspective side view thereof;

FIG. 10 is a perspective side view of the hemostasis device of FIG. 4,with the balloon assembly in an inflated state, attached around an armof a patient;

FIG. 11 is a top view of a folded balloon assembly according to anotherembodiment of the present disclosure, in an uninflated state;

FIG. 12 is a schematic top view thereof, shown unfolded while in anuninflated state;

FIG. 13 is a perspective side view of the balloon assembly of FIG. 11,shown in an inflated state, used as part of a hemostasis device which isattached around an arm of a patient;

FIG. 14 is a top view of a folded balloon assembly according to anotherembodiment of the present disclosure, in an uninflated state;

FIG. 15 is a schematic top view thereof, shown unfolded while in anuninflated state;

FIG. 16 is a perspective side view of the balloon assembly of FIG. 14,shown in an inflated state, used as part of a hemostasis device which isattached around an arm of a patient;

FIG. 17 is a top view of a folded balloon assembly according to anotherembodiment of the present disclosure, in an uninflated state;

FIG. 18 is a schematic top view of a folded balloon assembly accordingto yet another embodiment of the present disclosure, shown unfoldedwhile in an uninflated state;

FIG. 19 is a schematic top view of a folded balloon assembly accordingto still another embodiment of the present disclosure, shown unfoldedwhile in an uninflated state;

FIG. 20 is a sectional view of a balloon assembly according to the priorart;

FIG. 21 is a sectional view of a balloon assembly according to thepresent disclosure; and

FIGS. 22 and 23 are schematic views of a balloon assembly according tothe present disclosure.

DETAILED DESCRIPTION OF THE EMBODIMENT(S)

The ensuing detailed description provides exemplary embodiment(s) only,and is not intended to limit the scope, applicability, or configurationthereof. Rather, the ensuing detailed description of the exemplaryembodiment(s) will provide those skilled in the art with an enablingdescription for implementing these embodiment(s). It should beunderstood that various changes may be made in the function andarrangement of elements of the embodiment(s) without departing from thespirit and scope of the invention, as set forth in the appended claims.

Directional terms (e.g., upper, lower, left, right, etc.) may be usedherein. These directional terms are merely intended to assist indisclosing the embodiment(s) and claiming the invention and are notintended to limit the claimed invention in any way. In addition,reference numerals that are introduced in the specification inassociation with a drawing figure may be repeated in one or moresubsequent figure(s) without additional description in thespecification, in order to provide context for other features.

Peripheral vascular interventions are commonly used to attempt to clearocclusions from, or surgically introduce stents into, vascular pathways.For example, antegrade crossing via the radial artery in a patient'swrist is common, and various retrograde approaches upwardly from below apatient's knee are also established procedures. After such a procedure,the vascular (i.e., either arterial or venous) access site is typicallyclosed through application of pressure to encourage hemostasis.

Hemostasis devices that are wrapped around a patient's limb at a site onthe limb where bleeding is to be stopped, and which include one or moreinflatable balloons or bladders that target pressure at a vascularaccess site, are known in the art. Multiple embodiments of one suchhemostasis device and methods of using such devices are described inU.S. Pat. No. 7,498,477, the entirety of which is incorporated byreference as if set forth herein. Additional embodiments of suchhemostasis devices and methods of using same are described in U.S.patent application Ser. No. 16/288,303, filed Feb. 28, 2019, theentirety of which is incorporated by reference as if set forth herein.It should be understood that the devices and methods taught herein couldbe used or adapted for use with any of the hemostasis devices taught inthe references noted above in this paragraph.

As discussed in the '477 Patent noted above, such hemostasis devicesgenerally include a rigid member (e.g., a curved plate that slips into aband) and at least one inflatable balloon that, when inflated, expandsin a direction away from the rigid member and presses into a targetedlocation on a patient's limb or other body part, thereby promotinghemostasis. Many of these devices have a dual-balloon design including aconnection port that connects the chambers of the two balloons influid-flow connection, such that inflating one balloon will cause thefluid (e.g., air) to flow through the connection port and fill the otherballoon. These connection ports are typically made via radio frequency(“RF”) welding or bonding between faces of the adjacent balloons. Insome instances these connection ports can fail, thus causing the balloonassembly of the hemostasis device to fail to properly inflate. Theconnection port design also requires multiple manufacturing steps andcostly and time-consuming manual placement of components during theconstruction process. Accordingly, there is a need for improved balloonassembly structures and methods of constructing same.

The present disclosure describes various embodiments of improved balloonassembly structures, each of which omit the connection port between theballoons. Several of these embodiments are formed of two or more layersof material (e.g., vinyl or PVC) connected together via a single weldedperimeter and then folded to form a balloon assembly that includes boththe large balloon and small balloon at the same time with an open airchannel between the two sections. Said another way, the two or moreballoon chambers and the air channel that connects between the balloonchambers collectively form a contiguous air chamber, with each componentof the contiguous air chamber having been at least partially formed by asingle welding step. In an alternative embodiment according to thepresent disclosure, a plurality of balloons are formed and amulti-output connector splits the inflation tubing into the appropriatenumber of output connection tubes, each of which is separately routedinto one of the plurality of balloons. In either approach, significantlyfewer manufacturing steps are needed, placement of the components of theballoon assembly is simpler and more automatable, and therelatively-weak connection port is eliminated.

Referring now to FIGS. 1-23, various embodiments of balloon assembliesfor hemostasis devices will be shown and described in detail. Thehemostasis devices shown in the Figures are generally designed to bewrapped and secured in place around the arm 2 of a patient near thewrist to encourage hemostasis of the radial artery, as would beunderstood by a person having ordinary skill in the art. However, itshould be understood that the concepts discussed in the presentdisclosure have applicability to other hemostasis devices that may beemployed elsewhere on a patient's body, for example on any portion ofany limb or the torso, neck, or head, and could be used for eitherarterial or venous hemostasis applications. Further, while it isgenerally desirable that the balloon assemblies according to the presentdisclosure be substantially transparent to permit visibility of thevascular access site (both for placement and for monitoring ofcomplications), in alternative embodiments these balloon assemblies maybe partially or entirely opaque.

FIG. 1 is a partial perspective view of a hemostasis device 10 includinga balloon assembly 16 according to the prior art, in an uninflatedstate. FIG. 2 shows this balloon assembly 16 by itself in an uninflatedstate. As shown in FIGS. 1 and 3, the balloon assembly 16 is attached toan interior side 13 of a band 12 that faces a patient's arm 2 when worn,the band 12 further comprising an an exterior side 14 opposing theinterior side 13 and an insert plate 15 inserted within layers (notlabeled) of the band 12. In this embodiment, the balloon assembly 16comprises a small balloon 18 that is attached to the interior side 13 ofthe band 12 via an attachment hinge 21 and a large balloon 24 that isattached to the interior side 13 of the band 12 via an attachment hinge25. A length of connection tubing 22 enters the balloon assembly 16 viaan inlet 20, and a connection port 26 is formed between the smallballoon 18 and large balloon 24 such that air entering the balloonassembly 16 via the connection tubing 22 can freely travel between theballoons 18,24 via the connection port 26. As noted above, theconnection port 26 is typically RF welded and is subject to occasionalfailure when the balloon assembly 16 is inflated (as shown in FIG. 3).

FIGS. 4-10 show various views of a balloon assembly 116 according to thepresent disclosure, and FIGS. 4 and 8-10 show the balloon assembly 116attached to a hemostasis device 110 according to the present disclosure.FIGS. 4-10 show a “reverse end-fold” design for a balloon assembly 116which has a single, welded outer perimeter 126 and a single, weldedinner perimeter 128 around which a pair of air channels 134 a,134 b areformed. In this embodiment, both perimeters 126, 128 are formed by laserwelding the material layers together, but other construction methods arepossible for connecting the material layers of the balloon assembly 116,for example but not limited to RF welding or gluing. In this embodiment,a cutout 130 is made within the inner perimeter 128 after it has beenformed so that the channels 134 a,134 b are separate portions which arelocated on opposite sides of the cutout 130. In the alternative, thecutout 130 may be omitted so that the inner perimeter 128 surrounds afully-welded region of two or more layers of material. In the presentembodiment, the balloon assembly 116 is fully constructed by beingfolded about the fold line 136 so that a folded portion 138 is formedthat includes the channels 134 a,134 b, and a small balloon 120 islocated atop a large balloon 122. In this and other embodimentsaccording to the present disclosure, placing the balloon assembly 116 inits folded configuration aligns a first portion of the channel 134 aatop a second portion of the channel 134 a and aligns a first portion ofthe channel 134 b atop a second portion of the channel 134 b.

Via a single welding step of forming the two perimeters 126,128, thefolded balloon assembly 116 of the present embodiment creates adual-balloon structure comprising the small balloon 120, the largeballoon 122, and the integrated air channels 134 a,134 b connecting theballoons 120,122, thereby achieving elimination of the weak weldedconnection port of the prior art devices while reducing the number ofsteps involved in the construction process. The small balloon 120, thelarge balloon 122, and the integrated air channels 134 a,134 bcollectively comprise a contiguous air chamber 160, each component ofwhich is formed at least in part by the single welding step. Moreparticularly, the small balloon 120 has a perimeter 121, the largeballoon 122 has a perimeter 123, and each of the air channels 134 a,134b has a respective perimeter 135 a,135 b, and at least a portion of eachof the perimeters 121,123,135 a,135 b—specifically, respective outeredge portions of each perimeter 121,123,135 a,135 b—is formed by theouter perimeter 126.

In the embodiment shown in FIGS. 4-10, the balloon assembly 116 iscomprised of three layers of material around its outer perimeter 126 andtwo layers of material around its inner perimeter 128. In alternativeembodiments, the balloon assembly 116 may be formed by attaching anyplural number of material layers together about either or both of theouter perimeter 126 and inner perimeter 128, in different combinations,as would be appreciated by a person having ordinary skill in the art.

Turning back to the embodiment of FIGS. 4-10, the balloon assembly 116is attached to the hemostasis device 110 via two separate attachmenthinges 140,142, but in alternative embodiments a reverse end-foldballoon assembly design could have a single, shared attachment hinge bywhich the balloon assembly is attached to a hemostasis device. Further,while in the present embodiment two air channels 134 a,134 b are formed,this type of balloon assembly design could be formed with any number ofair channels between the balloons 120,122.

In the present embodiment, the balloon assembly 116 includes anindicator 124 located on the large balloon 122 that is used to help theclinician properly align the hemostasis device 110 on the patient's bodypart (i.e., adjacent to or atop the vascular access site) before,during, or after inflation of the balloon assembly 116. Omitting awelded connection port from the balloon assembly 116 provides theadditional benefit of enhancing the visibility of the indicator 124 andthe underlying vascular access site, thereby increasing the likelihoodthat the clinician will perform the hemostasis procedure accurately. Inalternative embodiments, the indicator 124 could be located elsewhere onthe balloon assembly 116, located elsewhere on the hemostasis device 110(e.g., on the band or rigid insert plate), or omitted entirely.

FIGS. 4 and 8-10 show the hemostasis device 110 comprising the balloonassembly 116 attached to a band 112 according to the disclosure of U.S.patent application Ser. No. 16/288,303. The hemostasis device 110further comprises a rigid insert plate 115 that acts to direct the forceof the inflated balloon assembly 116 towards the vascular access site,and complementary fastener patches 113,114 (e.g., of hook-and-loop type,though other fastener types are possible) located on the band 112 thatare used to close and secure the band 112 around a patient's body part.In this embodiment, the balloon assembly 116 is inflatable via aconnector and valve assembly 146 that is connected to an inlet 118 ofthe balloon assembly 116 for introduction of air into the balloonassembly 116 via a connection tubing 144. In this embodiment, theconnector and valve assembly 146 is comprised of a hard connector havingan integrated connector port 148 that mates only with the complementaryinflator tip 152 of an inflator 150. In this embodiment, the inflator150 comprises a collar 154 that surrounds the inflator tip 152 andprevents accidental or negligent misuse of the inflator 150, for exampleany attempt to insert the inflator tip 152 directly into an introducersheath used during a vascular access procedure.

FIGS. 11-13 show a balloon assembly 216 according to another embodimentof the present disclosure, and FIG. 13 shows the balloon assembly 216attached to a hemostasis device 210 having a band 212 that is attachedaround the arm 2 of a patient in the vicinity of the patient's wrist.FIGS. 11-13 show a “side fold” design of the balloon assembly 216 whichhas a single, outer laser-welded perimeter that forms a channel 234 thatconnects a small balloon 220 and a large balloon 222 together in fluidflow communication. A connection tubing 244 enters the balloon assembly216 via an inlet 218 that allows for introduction of air into theballoon assembly 216. Via a single welding step, the folded balloonassembly 216 of the present embodiment creates a dual-balloon structurecomprising the small balloon 220, the large balloon 222, and theintegrated channel 234, thereby achieving elimination of the weldedconnection port of the prior art devices. As shown in FIG. 12, theballoon assembly 216 is completed by folding it about the fold line 236to create a folded portion 238, and such that a first portion of thechannel 234 is placed atop a second portion of the channel. In thisembodiment, the balloon assembly 216 is attached to the hemostasisdevice 210 via a single attachment hinge 240, but in alternativeembodiments a side fold balloon assembly design could have two separateattachment hinges by which the balloon assembly is attached to ahemostasis device. As shown in FIG. 12 and further described in detailbelow, a “breather” strip 235, layer, or other component can optionallybe included within the channel 234 to help prevent material adhesionbetween the two layers of the balloon assembly 216 or kinking of thechannel 234, thus reducing the likelihood that the channel 234 will failto inflate, causing the balloon assembly 216 to fail.

In some embodiments according to the present disclosure, when theballoon assembly is attached to the band of the hemostasis device in itsintended configuration, there is some possibility that the foldedchannel could become tightly creased such that airflow is all orpartially kinked off between the balloons. In the various embodimentsdescribed herein, one or more pieces of secondary material canoptionally be included within each channel to help hold the channelopen. These “breather strips” may be one or more additional pieces ofmaterial included within the channel, which may be comprised of eitherair-permeable or air-impermeable materials. Alternatively, or inaddition, the channel(s) can be partially held open along their edge(s)by creating height along the one or more perimeter(s) of the balloonassembly construction using: one or more additional layer(s) ofmaterial; a glue line; and/or an extruded bead or weld line resultingfrom a RF welding process, along the one or more perimeter(s).

FIGS. 14-16 show a balloon assembly 316 according to another embodimentof the present disclosure, and FIG. 16 shows the balloon assembly 316attached to a hemostasis device 310 having a band 312 that is attachedaround the arm 2 of a patient in the vicinity of the patient's wrist.FIGS. 14 and 15 show a “center vent” folded design that is a form of endfold design in which an air channel 334 is created in the center of aside edge of the balloon assembly 316. In this embodiment, the balloonassembly 316 has single, outer laser-welded perimeter that forms thesingle air channel 334 connecting a small balloon 320 and large balloon322 together in fluid flow communication. In this embodiment, theremainder of the side edge that includes the air channel 334 is sealedand serves as an attachment hinge 340 for connecting the balloonassembly 316 to the hemostasis device 310. A connection tubing 344enters the balloon assembly 316 via an inlet 318 that allows forintroduction of air into the balloon assembly 316. Via a single weldingstep, the folded balloon assembly 316 of the present embodiment createsa dual-balloon structure comprising the small balloon 320, the largeballoon 322, and the integrated channel 334, thereby achievingelimination of the welded connection port of the prior art devices. Asshown in FIG. 15, the balloon assembly 316 is completed by folding itabout the fold line 336 to create a folded portion 338, and such that afirst portion of the channel 334 is placed atop a second portion of thechannel 334. In this embodiment, the balloon assembly 316 is attached tothe hemostasis device 310 via a single attachment hinge 340 that islocated along the same edge of the balloon assembly 316 as the channel334. In alternative embodiments, a “center-vent” end-fold balloonassembly design could have one or two separate attachment hinges locatedon the edge of the balloon assembly 316 opposing the edge where thechannel 334 is located (i.e., on the edges of the small balloon 320and/or large balloon 322 shown on the right side in the view of FIG.14). In this embodiment, a breather strip 335 may be optionally includedwithin the channel 334.

FIG. 17 shows another embodiment of a balloon assembly 410 according tothe present disclosure. In this embodiment, rather than a single foldedballoon design with a direct, integral air channel, the balloon assembly410 is formed of two separate balloons, a small balloon 424 and a largeballoon 418, that are not directly connected together in fluid flowcommunication via an integral channel. Instead, a Y-shaped connector 412that has a single air inlet and two air outlets is used, with a firstconnection tubing 414 routed between one of the air outlets (notlabeled) of the Y-shaped connector 412 and an inlet 416 on the largeballoon 418 and a second connection tubing 420 routed between the otherof the air outlets (not labeled) of the Y-shaped connector 412 and aninlet 422 of the small balloon 424. In this embodiment, the balloonassembly 410 is attachable to a hemostasis device via a singleattachment hinge 426, but in alternative embodiments a multi-balloonassembly design with separated air input lines could have separateattachment hinges by which the balloon assembly is attached to ahemostasis device.

Rather than using connection tubing to feed air through an inlet that islocated along a side edge of the balloon assembly, balloon assembliesaccording to the present disclosure could also utilize a “chimney”-styleport that is routed perpendicularly to the surfaces of the balloon(s).FIGS. 18 and 19 show, respectively, schematic views of a side-foldballoon assembly 516 and a “center-vent” end-fold balloon assembly 616,which include respective chimney ports 518,618 that form the air inletfor the respective balloon assembly 516,616. It should be understoodthat balloon assembly 516 is otherwise functionally similar to balloonassembly 216 of FIGS. 11-13 and that balloon assembly 616 is otherwisefunctionally similar to balloon assembly 316 of FIGS. 14-16, with likeparts in the embodiments of FIGS. 18 and 19 labeled with referencenumerals increased by a value of 300 with respect to the respectiverelated embodiment.

While the embodiments discussed above are designed as two-balloonstructures, additional folds or split air lines could be used to form aballoon assembly having any number of balloons or separate air chambersin accordance with the inventive concepts taught herein. Further, inaccordance with any of the embodiments, structures, concepts, or methodstaught herein, the channel(s) or air passages between the balloons couldbe of any number, could be of any non-linear shape (e.g., angled,zig-zagged, curved), and/or could split, combine, or both. Inalternative embodiments, any connection tubing could be replaced by a“chimney port” or hose barb.

Another drawback with the structure of existing balloon assemblies isexpansion defects or failures caused by the top and bottom layers ofballoons adhering to another and failing to properly separate and permitthe balloon to inflate after long periods of having been adjacent toanother (i.e., after long periods of the balloon being uninflated).Referring now to FIG. 20, a sectional view of a balloon assembly 710according to the prior art is shown in an uninflated state, with a toplayer 712 and a bottom layer 714 thereof shown adjacent to another withno air gap or space between the layers 712,714.

In some embodiments according to the present disclosure, this expansionfailure is addressed by including spacer(s), strip(s), and/or additionallayer(s) of material between the top and bottom layers of the balloon,or otherwise forming space(s) between the layers of material. Materialscan be added within formed air channel(s) to prevent these air pathsfrom sealing off when the balloon assembly is folded. These “breatherstrips” are formed from air-permeable materials, including but notlimited to felt, thread, paper, and porous plastic. In alternativeembodiments, non-permeable materials can be placed such that they propopen air channel(s), thus allowing air to pass through the channel(s)adjacent to the material. Suitable non-permeable materials include butare not limited to tubing, stickers (adhesive backed paper), flexiblesheets of either similar or dissimilar material to the material of theflexible sheet of the balloon, and/or cured glue. Holding channel(s)open at their edges via non-permeable materials, as shown in the exampleof FIG. 21 below, achieves the same effect as inserting air-permeable“breather strips” between layers of the balloon to form air channel(s).These space(s) may be located in the vicinity of the air injection portsuch that when air is injected into the balloon(s) the space serves as atrigger that helps peel apart any adhesions between the layers as aircontinues to flow into the balloon(s). Breather strips may be of anysuitable cross-sectional shape, including but not limited to circular,oval, or rectangular.

FIG. 21 shows a sectional view of a balloon assembly 810 according tothe present disclosure in an uninflated state, with a top layer 812 anda bottom layer 814 thereof shown mostly adjacent to another, but furtherincluding spacers 816,820 along the side edges (perimeter) of theballoon assembly 810 that introduce respective air gaps 818,822 adjacentto the spacers 816,820, such that when air is introduced into theballoon assembly 810 between the top layer 812 and bottom layer 814, theair gaps 818,822 created by the spacers 816,820 serve as air flow pathsthat promote proper inflation of the balloon assembly 810, overcomingany adherence between the two layers 812,814. It should be understoodthat the assembly shown in FIG. 21 could be representative of the entirecross-section of a balloon assembly, or instead of one channel of amulti-channel balloon assembly. It should further be understood that aspacer or third layer of material could be included around one edge(e.g., outer perimeter) of the assembly or channel, while another edge(e.g., inner perimeter) is comprised of only two material layers.

FIGS. 22 and 23 schematically depict a balloon assembly 910 thatincludes one (or more) intermediate layer(s) used as spacer(s) betweentop and bottom layers thereof. FIG. 22 schematically depicts an unfoldedballoon assembly 910 formed by bonding or laser welding a top layer 922,middle layer 924, and bottom layer 926 together via a weld line 912located around an exterior perimeter of the balloon assembly 910, and aweld line 914 located around an interior perimeter of the balloonassembly 910, with the top layer 922 and bottom layer 926 welded (orbonded) together via the exterior weld line 912 at the perimeter(leaving space 918 for an air inlet), and the middle layer 924 welded(or bonded) to both of the top layer 922 and the bottom layer 926 viaweld line 914 to act as a spacer therebetween (the squares projectingupwardly and downwardly from the middle layer 924 in FIG. 23 depict theweld/bonding locations to the respective layers 922,926). The weld line914 creates a pair of channels 916 a,916 b on either side thereof, suchthat when the balloon assembly 910 is folded about fold line 920 to forma completed balloon, air can travel through these channels 916 a,916 bbetween the two formed balloon chambers. The balloon assembly 910 of thepresent embodiment has both two- and three-layer portions, with thethree-layer portions acting to prevent expansion failure in theremainder of the balloon assembly 910. In this embodiment, once foldedit is possible to cut out the interior area of the center welded area(the area inside weld line 914), since this is not necessary for properfunctioning of the balloon assembly 910. By this method, an “end-fold”balloon assembly—similar to the balloon assembly 116 of FIGS. 4-10—isconstructed.

While the principles of the claimed invention have been described abovein connection with specific embodiment(s), it is to be clearlyunderstood that this description is made only by way of example and notas a limitation of the scope of the invention, as set forth in theappended claims.

1. A balloon assembly for a hemostasis device, the balloon assemblycomprising: a first chamber; a second chamber; and at least one channelthat is in fluid flow communication between the first chamber and thesecond chamber, wherein a single perimeter of attachment between a firstlayer of material and a second layer of material defines at least aportion of a perimeter of the first chamber, at least a portion of aperimeter of the second chamber, and at least a portion of a perimeterof the at least one channel.
 2. The balloon assembly of claim 1, whereinthe single perimeter of attachment defines the entireties of theperimeters of the first chamber and the second chamber.
 3. The balloonassembly of claim 2, wherein the single perimeter of attachment definesthe entirety of the perimeter of the at least one channel.
 4. Theballoon assembly of claim 1, the balloon assembly further comprising anexterior edge, wherein the at least one channel is folded around theexterior edge and wherein at least a portion of the first chamberoverlays at least a portion of the second chamber.
 5. The balloonassembly of claim 4, wherein a first portion of the at least one channeloverlays a second portion of the at least one channel.
 6. The balloonassembly of claim 1, further comprising at least one piece of secondarymaterial located within the at least one channel.
 7. The balloonassembly of claim 6, wherein the at least one piece of secondarymaterial is formed of a gas-permeable material.
 8. The balloon assemblyof claim 6, wherein the at least one piece of secondary material isformed of a gas-impermeable material.
 9. The balloon assembly of claim6, wherein the at least one piece of secondary material has a circularcross-sectional shape.
 10. The balloon assembly of claim 1, furthercomprising a third layer of material that is at least partially locatedbetween and attached to the first layer of material and the second layerof material.
 11. The balloon assembly of claim 1, the single perimeterof attachment comprising an outer perimeter, the balloon assemblyfurther comprising an inner perimeter of attachment between the firstlayer and the second layer, the inner perimeter being located interiorto the outer perimeter.
 12. The balloon assembly of claim 11, whereinthe outer perimeter and the inner perimeter form a first air channel anda second air channel between the first chamber and the second chamber.13. The balloon assembly of claim 12, further comprising a cutout regioninterior to the inner perimeter from which portions of the first layerof material and second layer of material are absent.
 14. The balloonassembly of claim 1, further comprising an inlet located along theperimeter through which a fluid can be introduced into an interior ofthe balloon assembly.
 15. The balloon assembly of claim 14, wherein theinlet is in the form of a hollow cylindrical tubing.
 16. (canceled) 17.(canceled)
 18. (canceled)
 19. (canceled)
 20. (canceled)
 21. A balloonassembly for a hemostasis device, the balloon assembly comprising: aconnector having a first air inlet, a first air outlet, and a second airoutlet, the first air inlet being connected separately in fluid flowcommunication with each of the first air outlet and the second airoutlet; a first balloon having an inlet and an interior; a firstconnection tubing connected in fluid flow communication between thefirst air outlet and the interior of the first balloon via the inletthereof; a second balloon having an inlet and an interior; and a secondconnection tubing connected in fluid flow communication between thesecond air outlet and the interior of the second balloon via the inletthereof; wherein the first balloon and the second balloon are notconnected in direct fluid flow communication.
 22. The balloon assemblyof claim 0, wherein the first balloon and second balloon are physicallyconnected together along a respective edge thereof.
 23. A balloonassembly for a hemostasis device, the balloon assembly comprising: afirst chamber; a second chamber; and at least one channel that is influid flow communication between the first chamber and the secondchamber; wherein the first chamber, the second chamber, and the at leastone channel are formed between a first layer of material and a secondlayer of material; wherein at least a portion of the first chamberoverlays at least a portion of the second chamber; and wherein the atleast one channel is folded.
 24. The balloon assembly of claim 0,wherein the at least one channel is wrapped around an exterior edge ofthe balloon assembly.
 25. The balloon assembly of claim 0, wherein theat least one channel is folded such that a first portion of the at leastone channel overlays a second portion of the at least one channel.